| 摘要 |
The invention relates to a controlled release composition comprising a combination of isosorbide dinitrate and hydralazine, such as hydralazine hydrochloride, that in operation delivers the drug in a pulsed or multi-modal manner for the treatment of angina, ischaemic heart disease, arterial hypertension and related disease conditions. Preferably, the isosorbide dinitrate and hydralazine hydrochloride can be released from the dosage form in an erodable, diffusion and/or osmotic-controlled release profile. |
| 主权项 |
1. A solid pharmaceutical composition for oral administration comprising:
a first population of active ingredient containing particles comprising isosorbide dinitrate, or a salt thereof, mannitol, and sugar spheres; a second population of active ingredient containing particles comprising hydralazine, or a salt thereof, sugar spheres, and at least one stabilizer selected from the group consisting of edetic acid, salts thereof, citric acid, and salts thereof; a third population of active ingredient containing particles comprising isosorbide dinitrate, or a salt thereof, mannitol, sugar spheres, and a protective coating selected from the group consisting of modified-release coatings and modified-release matrix coatings; and a fourth population of active ingredient containing particles comprising hydralazine, or a salt thereof, sugar spheres, at least one stabilizer selected from the group consisting of edetic acid, salts thereof, citric acid, and salts thereof, and a coating selected from the group consisting of modified-release coatings and modified-release matrix coatings;wherein the amount of isosorbide dinitrate contained therein is in an amount of from about 0.1 mg to about 1 g; andwherein the amount of hydralazine contained therein is in an amount of from about 0.1 mg to about 1 g. |
